RAPID REPAIR BALM- skin protectant ointment
Skinfix, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Rapid Repair Balm

ACTIVE INGREDIENT

ZINC OXIDE 20%

PURPOSE

SKIN PROTECTANT

KEEP OUT OF REACH OF CHILDREN

USES

WARNINGS

DIRECTIONS

INACTIVE INGREDIENTS

Rapid Repair Balm 120g Label photo

RAPID REPAIR BALM
skin protectant ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61328-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	.20 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
ALCOHOL (UNII: 3K9958V90M)
SOYBEAN OIL (UNII: 241ATL177A)
SUNFLOWER OIL (UNII: 3W1JG795YI)
JOJOBA OIL (UNII: 724GKU717M)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61328-003-03	120 g in 1 TUBE; Type 0: Not a Combination Product	12/09/2013	09/22/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	12/09/2013	09/22/2016

Labeler - Skinfix, Inc. (203158183)

Registrant - Product Integrity Laboratory, LLC (783863694)

Name	Address	ID/FEI	Business Operations
Establishment
Canadian Custom Packaging Company		207062514	manufacture(61328-003)

Revised: 9/2016

Document Id: 002972c4-729b-4e3e-a882-8507ac8cbb64

Set id: e30f8337-ec34-4cf8-b4a1-e90da3912e1c

Version: 3

Effective Time: 20160922

Skinfix, Inc.