MedPath

Healing Hand Cream

CCC Healing Hand Cream

Approved
Approval ID

3dd5887f-a26b-01ef-e063-6394a90a0c52

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 2, 2025

Manufacturers
FDA

Carolina Cannabis Creations LLC

DUNS: 118697474

Products 1

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

Allantoin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82876-224
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
Allantoin
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 2, 2025
FDA Product Classification

INGREDIENTS (22)

ALLANTOINActive
Quantity: 0.85 g in 118.76 g
Code: 344S277G0Z
Classification: ACTIB
COCONUT OILInactive
Quantity: 2.21 g in 118.76 g
Code: Q9L0O73W7L
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 0.85 g in 118.76 g
Code: LKG8494WBH
Classification: IACT
GLYCERINInactive
Quantity: 6.65 g in 118.76 g
Code: PDC6A3C0OX
Classification: IACT
BEEF TALLOWInactive
Quantity: 2.42 g in 118.76 g
Code: 98HPY76U4W
Classification: IACT
XANTHAN GUMInactive
Quantity: 0.34 g in 118.76 g
Code: TTV12P4NEE
Classification: IACT
STEARIC ACIDInactive
Quantity: 1.1 g in 118.76 g
Code: 4ELV7Z65AP
Classification: IACT
DEHYDROACETIC ACIDInactive
Quantity: 0.08 g in 118.76 g
Code: 2KAG279R6R
Classification: IACT
JOJOBA OILInactive
Quantity: 2.21 g in 118.76 g
Code: 724GKU717M
Classification: IACT
PEG-8 BEESWAXInactive
Quantity: 1.11 g in 118.76 g
Code: 3C1QUF1TIR
Classification: IACT
ALMOND OILInactive
Quantity: 1.11 g in 118.76 g
Code: 66YXD4DKO9
Classification: IACT
CETEARYL OLIVATEInactive
Quantity: 2.664 g in 118.76 g
Code: 58B69Q84JO
Classification: IACT
ROSEMARY OILInactive
Quantity: 0.66 g in 118.76 g
Code: 8LGU7VM393
Classification: IACT
RICE BRAN OILInactive
Quantity: 4.44 g in 118.76 g
Code: LZO6K1506A
Classification: IACT
SHEA BUTTERInactive
Quantity: 1.11 g in 118.76 g
Code: K49155WL9Y
Classification: IACT
CANNABIDIOLInactive
Quantity: 2.7 g in 118.76 g
Code: 19GBJ60SN5
Classification: IACT
ARNICA MONTANA FLOWER WATERInactive
Quantity: 2.1 g in 118.76 g
Code: U7L2JP51PR
Classification: IACT
SODIUM PHYTATEInactive
Quantity: 0.11 g in 118.76 g
Code: 88496G1ERL
Classification: IACT
WATERInactive
Quantity: 83.07 g in 118.76 g
Code: 059QF0KO0R
Classification: IACT
CEDRUS ATLANTICA WOOD OILInactive
Quantity: 0.44 g in 118.76 g
Code: JEX140NPX8
Classification: IACT
TOCOPHEROLInactive
Quantity: 0.66 g in 118.76 g
Code: R0ZB2556P8
Classification: IACT
SORBITAN OLIVATEInactive
Quantity: 1.776 g in 118.76 g
Code: MDL271E3GR
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/2/2025

Jar front label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/1/2023

Uses

helps prevent and temporarily protects and helps relieve chafed, chapped, or
cracked skin • helps prevent and protect from the drying effects of wind and cold weather

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/1/2025

Active Ingredients

Allantoin 0.72% .................................................................................................. Skin Protectant

Purpose

Allantoin 0.72% .................................................................................................. Skin Protectant

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 8/1/2023

Other information

Store at 68-77 degrees F, Avoid direct sunlight

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 8/1/2025

When using this product

Do not get into eyes

on deep or puncture wounds • animal bites • serious burns

WARNINGS SECTION

LOINC: 34071-1Updated: 8/1/2025

Warnings

FOR EXTERNAL USE ONLY.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/1/2025

Stop use and ask a doctor if

The condition worsens, symptoms last more than 7 days, the condition clears but occurs again within a few days.

Stop use and ask a doctor if

Condition worsens, Symptoms last more than 7 days, Condition clears up but occurs again within a few days.

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 8/1/2023

If pregnant or breastfeeding

Consult a health professional before use

In case of an overdose

seek medical help or contact a poison control center right away

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/1/2025

Directions

• Adults and children 2 years of age and older: Apply as needed
• Children under 2 years of age: Do not use, consult a doctor

Keep out of reach of children

keep out of reach of children

Keep out of reach of children

keep out of reach of children

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/1/2025

Inactive ingredients

Arnica oil, Beeswax, Cedarwood oil, Cetearyl olivate, Coconut oil, Glycerin, Hemp
extract (Full Spectrum), Jojoba oil, Rice bran oil, Rosemary oil, Shea butter, Sodium
phytate, Sorbitan olivate, Stearic acid, Sweet almond oil, Tocopherol, Water

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