BODY REPAIR BALM- oatmeal ointment

Body Repair Balm by

Drug Labeling and Warnings

Body Repair Balm by is a Otc medication manufactured, distributed, or labeled by Skinfix, Inc., Product Integrity Laboratory, LLC, Canadian Custom Packaging Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Colloidal Oatmeal  2%

Purpose

Skin protectant

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to . eczema . rash . dermatitis

Warnings

For external use only

When using this product -

Avoid contact with eyes

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

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center right away

Directions

Apply balm liberally as needed, especially after bathing.

Other information

- Store at 65 - 80F - May stain fabrics - For adults and children two year of age and older

Inactive Ingredients

allantoin, aloe barbadensis leaf juice, beeswax, butyrospermum parkii (shea butter), glycine soja (soybean) oil, liquidambar orientalis (styrax), myroxylon balsumum (balsam tolu), paraffin wax, petrolatum, prunus amygdalus dulcis (sweet almond) oil, simmondsia chinensis (jojoba) seed oil, styrax benzoin resin extract (benzoin), tocopherol, zinc oxide

Package Label Principal Display

Skinfix

Body Repair Balm

Treats eczema, dryness, dermatitis

INGREDIENTS AND APPEARANCE

BODY REPAIR BALM 
oatmeal ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61328-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	0.2 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ZINC OXIDE (UNII: SOI2LOH54Z)
PETROLATUM (UNII: 4T6H12BN9U)
SOYBEAN OIL (UNII: 241ATL177A)
JOJOBA OIL (UNII: 724GKU717M)
SHEA BUTTER (UNII: K49155WL9Y)
ALMOND OIL (UNII: 66YXD4DKO9)
TOCOPHEROL (UNII: R0ZB2556P8)
WHITE WAX (UNII: 7G1J5DA97F)
PARAFFIN (UNII: I9O0E3H2ZE)
ALLANTOIN (UNII: 344S277G0Z)
BENZOIN RESIN (UNII: GK21SBA74R)
LIQUIDAMBAR ORIENTALIS RESIN (UNII: 63V91G4W93)
TOLU BALSAM (UNII: TD2LE91MBE)
ALOE (UNII: V5VD430YW9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61328-009-03	120 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/09/2013

Labeler - Skinfix, Inc. (203158183)

Registrant - Product Integrity Laboratory, LLC (783863694)

Establishment
Name	Address	ID/FEI	Business Operations
Canadian Custom Packaging Company		207062514	manufacture(61328-009)