MedPath

Acne Rescue

DRUG FACTS:

Approved
Approval ID

0f4d02cb-dc59-4fe4-b6d1-e9a7a81139a9

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 21, 2025

Manufacturers
FDA

Peaceful Mountain, Inc.

DUNS: 078430707

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Borax, Carbo Vegetabilis, Carboneum Sulphuratum, Causticum, Natrum Muriaticum, Silicea

PRODUCT DETAILS

NDC Product Code43846-0039
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationTOPICAL
Effective DateMay 21, 2025
Generic NameBorax, Carbo Vegetabilis, Carboneum Sulphuratum, Causticum, Natrum Muriaticum, Silicea

INGREDIENTS (31)

SODIUM BORATEActive
Quantity: 30 [hp_X] in 1 g
Code: 91MBZ8H3QO
Classification: ACTIB
ACTIVATED CHARCOALActive
Quantity: 12 [hp_X] in 1 g
Code: 2P3VWU3H10
Classification: ACTIB
CARBON DISULFIDEActive
Quantity: 12 [hp_X] in 1 g
Code: S54S8B99E8
Classification: ACTIB
CAUSTICUMActive
Quantity: 12 [hp_X] in 1 g
Code: DD5FO1WKFU
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 30 [hp_X] in 1 g
Code: 451W47IQ8X
Classification: ACTIB
SILICON DIOXIDEActive
Quantity: 30 [hp_X] in 1 g
Code: ETJ7Z6XBU4
Classification: ACTIB
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
ARNICA MONTANAInactive
Code: O80TY208ZW
Classification: IACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 71DD5V995L
Classification: IACT
LARREA TRIDENTATA TOPInactive
Code: PK0TXD049P
Classification: IACT
COMFREY LEAFInactive
Code: DG4F8T839X
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
LAVANDULA ANGUSTIFOLIA FLOWERInactive
Code: 19AH1RAF4M
Classification: IACT
MELISSA OFFICINALIS LEAFInactive
Code: 50D2ZE9219
Classification: IACT
OREGANOInactive
Code: 0E5AT8T16U
Classification: IACT
POLYETHYLENE GLYCOL 1500Inactive
Code: 1212Z7S33A
Classification: IACT
PEG-8 DIMETHICONEInactive
Code: GIA7T764OD
Classification: IACT
POLYETHYLENE GLYCOL 700Inactive
Code: 762678AC5R
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
PHYTOLACCA AMERICANA FRUITInactive
Code: WE63661499
Classification: IACT
PHYTOLACCA AMERICANA ROOTInactive
Code: 11E6VI8VEG
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYPERICUM PERFORATUMInactive
Code: XK4IUX8MNB
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
SALIX ALBA BARKInactive
Code: 205MXS71H7
Classification: IACT
ACHILLEA MILLEFOLIUM FLOWERInactive
Code: YQR8R0SQEA
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/16/2018

PACKAGE LABEL DISPLAY:

acne

rescue

homeopathic

gel

Fast acting, natural

formula providing

temporary relief from

unsightly skin

conditions such as

acne and rosacea.

peaceful mountain

THE HEIGHT OF HEALTH

Net wt. 0.5 oz. (14 g)

Acne Rescue tube

Acne Rescue carton

Acne Rescue tube

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/16/2018

INDICATIONS:

Temporarily relieves symptoms associated with acne: • pimples • redness • itching • inflammation.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/16/2018

ACTIVE INGREDIENTS:

Borax 30X, Carbo Vegetabilis 12X, Carboneum Sulphuratum 12X, Causticum 12X, Natrum Muriaticum 30X, Silicea 30X.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/16/2018

USES:

Temporarily relieves symptoms associated with acne: • pimples • redness • itching • inflammation.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

WARNINGS SECTION

LOINC: 34071-1Updated: 1/8/2015

WARNINGS:

For external use only.

**When using this product**

• Do not get into eyes

Stop use and ask a doctor if

• Condition worsens

• Symptoms last more than 7 days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

**If pregnant or breast-feeding,** ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 1/8/2015

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/8/2015

DIRECTIONS:

Apply twice daily over affected area. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/16/2018

INACTIVE INGREDIENTS:

Aloe Barbadensis Leaf Juice (Aloe Vera 10x Concentrate), Arnica Montana (Flower), Carbomer (Ultrez 21), Larrea Tridentata (Leaf), Symphytum Officinale (Leaf), Edetate Disodium (EDTA), Lavandula Angustifolia (Buds), Melissa Officinalis (Leaf), Natural Plant Extract (Origanox WS), [PEG-33, PEG-8 Dimethicone, PEG-14 (Silsense Copolyol-1 Silicone)], [Phenoxyethanol, Caprylyl Glycol, Sorbic Acid (Optiphen-Plus)], Phytolacca Americana (Berry), Phytolacca Americana (Root), Potassium Sorbate, Purified Water, Sodium Hydroxide (Solution), Hypericum Perforatum (Aerial Parts), Vitamin C (Powder) [Ascorbic Acid], Tocopherol [Vitamin E Oil](Derived From Soy Bean), Salix Alba (Bark), Achillea Millefolium (Flower).

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 1/16/2018

QUESTIONS:

888-303-3388 Mon-Fri 8 a.m.-5 p.m. CST

Dist. by Peaceful Mountain, Inc., Woodbine, IA 51579 ι www.peacefulmountain.com

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Acne Rescue - FDA Drug Approval Details