UNIQUE NATURAL PREMIUM SHEA BUTTER FRAGRANCE-FREE- shea butter cream

UNIQUE NATURAL PREMIUM SHEA BUTTER by

Drug Labeling and Warnings

UNIQUE NATURAL PREMIUM SHEA BUTTER by is a Homeopathic medication manufactured, distributed, or labeled by NATURAL COSMETICS INDUSTRY LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT:

SHEA BUTTER 99.5%

PURPOSE

PURPOSE:

SKIN PROTECTANT​

INDICATIONS & USAGE

USES:

TEMPORARILY PROTECTS AND HELPS RELIEVE MINOR SKIN IRRITATION AND ITCHING DUE TO

• ECZEMA
• RASHES

WARNINGS

WARNING:

FOR EXTERNAL USE ONLY.

STOP USE

STOP USE AND ASK A DOCTOR IF

• CONDITION WORSENS
• SYMPTOMS LAST MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS

WHEN USING

WHEN USING THIS PRODUCT

• DO NOT GET INTO EYES.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

DOSAGE & ADMINISTRATION

DIRECTIONS

• APPLY AS NEEDED

INACTIVE INGREDIENT

INACTIVE INGREDIENTS

• NONE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UNIQUE NATURAL PREMIUM SHEA BUTTER  FRAGRANCE-FREE
shea butter cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61515-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SHEA BUTTER (UNII: K49155WL9Y) (SHEA BUTTER - UNII:K49155WL9Y)	SHEA BUTTER	99.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61515-103-13	90 g in 1 JAR
2	NDC: 61515-103-18	250 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/29/2013

Labeler - NATURAL COSMETICS INDUSTRY LTD (217176902)

Establishment
Name	Address	ID/FEI	Business Operations
NATURAL COSMETICS INDUSTRY LTD		217176902	manufacture(61515-103)