Baby Diaper Changing Gloves with Skin Protectant (81310-009-12)

Baby Diaper Changing Gloves with Skin Protectant by

Drug Labeling and Warnings

Baby Diaper Changing Gloves with Skin Protectant by is a Otc medication manufactured, distributed, or labeled by Stretton Online Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BABY DIAPER CHANGING GLOVES WITH SKIN PROTECTANT- dimethicone cloth 
Stretton Online Ltd.

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Baby Diaper Changing Gloves with Skin Protectant (81310-009-12)

DRUG FACTS
Active Ingredient

Dimethicone 3% (w/w)

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve dry or cracked skin

Beneficial for face, hands, body, and legs

Warnings

For external use only.

Do not use

on deep or pouncture wounds

on animal bites

on serious burns

When using this product

Do not get into eyes

Stop use and ask a doctor if

• contition 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

Open package at the top and remove one glove at a time

Place the glove on your hand and use directly on the skin you wish to clean. Multiple gloves may be required for large soiled areas to avoid cross-contamination and spreading of germs.

If you wish to warm the gloves before use, follow the mircrowave instructions on the right of the pack.

Use as frequently as needed.

Other information

Store at room temperature

Inactive ingredients

Water, fragrance, panthenol, glycerin, allantoin, tocopheryl acetate, aloe barbadensis extract, chamomilla recutita extract, chlorhexidine digluconate, polysorbate 20, linoleanmidopropyl PG dimonium chloride phosphate, lauryl glucoside, citric acid, phenoxyethanol, ethylhexylglycerin

Label Images

Baby Diaper Changing Gloves

81310-009-12

12 count

BABY DIAPER CHANGING GLOVES WITH SKIN PROTECTANT 
dimethicone cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81310-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PANTHENOL (UNII: WV9CM0O67Z)
GLYCERIN (UNII: PDC6A3C0OX)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMOMILE (UNII: FGL3685T2X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LINOLEAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)
ALLANTOIN (UNII: 344S277G0Z)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81310-009-12	12 in 1 BOX	12/13/2021
1		20 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	12/13/2021	12/21/2023

Labeler - Stretton Online Ltd. (220633327)

Revised: 12/2023

Document Id: 0d0b9493-0c24-220a-e063-6294a90ab139

34390-5

Set id: d30e09d8-787e-728f-e053-2a95a90afd2b

Version: 4

Effective Time: 20231221