SKIN MOISTURIZING WITH NATURAL COLLOIDAL OATMEAL- dimethicone lotion
APOLLO HEALTH AND BEAUTY CARE

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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BACK LABEL - DRUG FACTS BOX

ACTIVE INGREDIENT

DIMETHICONE 1.25% (SKIN PROTECTANT)

WARNING

FOR EXTERNAL USE ONLY.

AVOID CONTACT WITH EYES, IF CONTACT OCCURS, RINSE EYE THROUGHLY WITH WATER.

STOP USING THIS PRODUCT AND ASK A DOCTOR IF

CONDITION WORSENS OR SYMPTOMS PERSIST FOR MORE THAN SEVEN DAYS OR OCCUR AGAIN WITHIN A FEW DAYS.

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

USES AND DIRECTIONS

USES: HELPS PREVENT AND TEMPORARILY PROTECTS CHAFED, CHAPPED OR CRACKED SKIN.

DIRECTIONS: APPLY AS NEEDED.

FRONT AND BACK LABELS

12OZ FRONT AND BACK LABELS: dgb12.jpg

OTHER INFORMATION

STORE AT ROOM TEMPERATURE.

SKIN MOISTURIZING WITH NATURAL COLLOIDAL OATMEAL
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63148-320
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1.2500 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63148-320-12	355 mL in 1 BOTTLE, PUMP

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	06/25/2010

Labeler - APOLLO HEALTH AND BEAUTY CARE (201901209)