AMORAY CARE BABY- mineral oil
MY IMPORT USA 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.

----------

Active Ingredient

MINERAL OIL USP 99.9 %

Purpose

Skin Protectant.

Uses

PROTECTS SKIN FROM DRYNESS, ITCHING, AND FLAKING.
SEALS IN MOISTURE.

Warnings

For external use only.

SAFETY TIP: CLOSE TIGHTLY AFTER USE AND KEEP OUT OF REACH OF CHILDREN. THIS PRODUCT IS NOT A TOY.

FOR BABIES: A SMALL AMOUNT IN THE DAILY BATH HELPS MOISTURIZE BABY'S DELICATE SKIN. GENTLY APPLY TO DIAPER AREA AND SCALP TO HELP PREVENT CHAFING AND DRY SKIN.

FOR ADULTS: USE AFTER SHOWER OR BATH ON WET SKIN AS A SKIN MOISTURIZER. ALSO USE AS AN EYE MAKEUP REMOVER HELPS SOFTEN DRY SKIN.

Inactive Ingredients

FRAGRANCE

Baby Oil 7 oz - A Baby Oil 12 oz - A

AMORAY CARE BABY
mineral oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51628-1008
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	99.9 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51628-1008-1	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/26/2015	02/10/2017
2	NDC:51628-1008-2	350 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/26/2015	02/10/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	03/26/2015	02/10/2017

Labeler - MY IMPORT USA INC (195767988)

Revised: 2/2017

Document Id: e5ecfc31-e876-4ceb-820f-e7f777065614

Set id: d6a608f7-ddf5-415f-8b02-c50b223699f9

Version: 2

Effective Time: 20170210

MY IMPORT USA INC